Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
This study is currently recruiting participants.
Verified November 2011 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01475513
First received: November 8, 2011
Last updated: November 16, 2011
Last verified: November 2011
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Purpose
Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
| Condition | Intervention | Phase |
|---|---|---|
|
Insulin Sensitivity Cardiovascular Risk Perimenopausal Disorder |
Drug: Ortho Cyclen® |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- Change from Baseline in Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Change from Baseline in Insulin Sensitivity at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Flow-mediated Vasodilatation at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Carotid Intima Media Thickness at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in Urinary Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Change from Baseline in Acute Insulin Response to Glucose at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Glucose Effectiveness in 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Disposition Index at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Fasting Insulin at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Fasting Glucose at 6 months [ Time Frame: Baseline, 3 monhts, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Areas-under-the-curve for Insulin at 6 months [ Time Frame: Baselines, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Areas-under-the-curve for Glucose at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Cardiovascular Markers (hsCRP, MCP-1, ICAM-1, V-CAM-1, PAI-1, tPA, RBP4) at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Blood Pressure at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Fasting Lipid Panel at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Change from Baseline in Body Mass Index in 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Change from Baseline in Waist-to-hip Ratio at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: African-American women
African-American women
|
Drug: Ortho Cyclen®
Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Other Names:
|
|
Active Comparator: Caucasian women
Caucasian women
|
Drug: Ortho Cyclen®
Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Other Names:
|
Detailed Description:
The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Premenopausal, regular-cycling women 18-35 years
- Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
- non-smoker.
Exclusion Criteria:
- Diabetes
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
- Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
- Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475513
Contacts
| Contact: Kai Cheang, Pharm. D. | 804-828-9698 | KICHEANG@VCU.EDU |
Locations
| United States, Virginia | |
| Virginia Commonwealth University Medical Center | Recruiting |
| Richmond, Virginia, United States, 23298-0111 | |
| Contact: Kai Cheang, Pharm. D. kicheang@vcu.edu | |
| Principal Investigator: Kai Cheang, Pharm. D. | |
Sponsors and Collaborators
Virginia Commonwealth University
American Heart Association
Investigators
| Principal Investigator: | Kai Cheang, Pharm. D. | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01475513 History of Changes |
| Other Study ID Numbers: | HM13769 |
| Study First Received: | November 8, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
oral contraceptive birth control pill women healthy volunteer insulin sensitivity insulin resistance |
cardiovascular risk factors endothelial function estrogen metabolism racial difference glucose intolerance |
Additional relevant MeSH terms:
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Contraceptive Agents Norgestimate, ethinyl estradiol drug combination Contraceptives, Oral Contraceptives, Oral, Combined Insulin |
Moxifloxacin Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Hypoglycemic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013